So, where do companies put things about their products in development or their product portfolio if they don't have or don't want to spend the money on product-specific websites? It's a good question.
In my opinion, corporate websites are designed for people interested in the company. Those would include investors and maybe, depending on how you look at it, payors, caregivers, HCPs or patients interested in researching a little more about a company in their research on treatments. So you have to put enough information on your website to peek the interest of investors and to give the rest of world a glimpse into what your company stands for. The conundrum, of course, is where does general information about a company and its products cross the line into specific information about products and, then, to product promotion?
The recent Vanda Pharmaceuticals letter sent out by OPDP is a case in point. In looking at the webpage cited it does have indication-like information about two products but not real claims. Just information about what the products do and pointing to the product website if the reader wants safety information.
To me certain things stand out about this letter:
- It appears that the violation was based on information that appeared on Vanda’s corporate website.
- As there is no mention of this website being submitted to OPDP under 2253, it is very possible that the company considered this was a corporate website and, therefore, non-promotional and so they didn't have to submit the content to OPDP.
- The violations cited were totally based on the company giving a pretty straightforward statement of what the product is used for. No real claims except the indication statement.
- Finally, it appears once again that OPDP is connecting a boxed warning product with the distinction of whether they send out an untitled or a warning letter.
The bottom line here is that OPDP does consider corporate
websites as potentially promotional and does review these ad hoc, looking for drug
promotion.
In my opinion this letter was sort of old school in that I think it was sent out, in part, to remind
companies to keep their corporate websites totally non-promotional. Consider yourselves reminded!
So how should companies avoid these types of situations?
1. Take a look at your corporate website content and consider whether someone could reasonably consider that it is promotional. Not whether YOU think it is promotional but whether some reasonable person might consider it promotional.
2. If you have product listings on your website or in a printed catalog be sure to group them in such a way that it doesn't appear that the grouping creates a claim. Ditto for any descriptions that go with those products. I am not saying to go crazy with this but consider if the grouping creates an indication for that drug.
3. Be sure that there isn't information on your corporate website about your drug or medical device that could be considered promotional. These could include language that has inferred promotion. Examples would be detailed mechanism of action discussions, summaries of what a drug is approved or being investigated for, detailed disease state discussions (especially if they go into the impact of or complications that could result from leaving a disease untreated or information about how current treatments are not completely effective) or anything else that could easily set the stage for drug promotion.
Look, any company that promotes their drug by doing more than handing out PIs is taking some risk that they may be violating ad/promo regulations. Three keys to help avoid getting an OPDP letter or have an DOJ investigation is to do things the right way, not make careless mistakes and, finally, consider that any violation is too small for OPDP to cite you for. Good luck!
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